Universidad Europea de Madrod
Villaviciosa de Odón, Spain
NCT Number: NCT06320171
The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). The investigators hypothesized that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Villaviciosa de Odón, Spain
The aim of the present study is to evaluate the acute effect immediately after the application of the NESA treatment in healthy participants in vascular sonographic variables measured in the left CCA such as the LD, IMT and PSV, as well as systolic (sBP) and diastolic blood (dBP) pressure and heart rate (HR). We hypothesize that NESA application will induce a direct influence in the vascular tone through the stimulation of the ANS and the parasympathetic nerve system. This premise is based on the fact that non-invasive NESA neuromodulation enhance the autonomic regulation of vascular tone and endothelial function.A total sample of forty participants (N = 40; mean age 26.6 ± 6.7 years) were recruited for participation in the study. Prior to entering the study, all participants received information about the study and signed a consent form to participate. The study subjects were divided into two equally distributed groups (A: NESA = 20; B: Placebo = 20) and were blinded to the study group allocation. Participants in the placebo group underwent the same procedural phases as those in the intervention group. However, for the placebo group, the device was set to deliver a low-intensity current below the sensory threshold, effectively rendering it inactive from the participants' perspective.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
Direct stimulation of the autonomic nervous system was achieved using Program 7 (P7) of the device, with a directional electrode positioned at the level of the C7 spinous process. P7 delivered a biphasic polarity current with oscillatory frequencies ranging from 1.92 to 14.29 Hz and variable intensities between 0.1 and 0.9 mA.
The placebo group followed the same procedure, except that no current was applied during their 20-minute session.
Time frame: before the intervention, and 10 minutes after the intervention
The pressure in the arteries during the contraction of the heart muscle. Measured with sphingomanometer.
Time frame: Before the intervention, and 10 minutes after the intervention
Hearbears per minute
Time frame: Before the intervention, and 10 minutes after the intervention
Cross-sectional area of the jugular vein
Time frame: Before the intervention, and 10 minutes after the intervention
Cross-sectional area of the common carotid
Time frame: Before the intervention, and 10 minutes after the intervention
Thickness of the common carotid
Time frame: Before the intervention, and 10 minutes after the intervention
Peak systolic velocity.
Time frame: Before the intervention, and 10 minutes after the intervention
Measure of cortisol level.
Universidad Europea de Madrid
Other
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